MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97715

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Sleep Dysfunction (2517)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins).Information was reported that the patient said since (b)(6) 2019 when she bares weight she feels pain where the ins is and it travels across her butt, hip, and down to her knee on her left side.The patient said that she had x-rays of her hip and knee and said that nothing is wrong.The patient is wondering if the ins could have shifted and is on a nerve.The patient mentioned that her insis for her si joint on her right side.It was recommended that the patient follow up with her healthcare provider (hcp).Additional information was received from the patient.It was reported that the hcp thought that the hcp thought the cause of the pain was the si joints.The patient said they had bilateral si joint injections ordered, dye #3, and prn for pain were done to resolve the issue.The pain was not yet resolved.Additional information was received from the patient.The patient wanted to address the questions.Patient reported she does not know if the pain was caused by the implant or not.Patient stated that she has been dealing with the pain and she stated her doctor informed her that the implant is not what was causing her the pain.Patient stated they were going to have to get two si injections and was hopefully getting an mri at least of her knee.Patient stated the pain has not resolved.Patient stated that she was in so much pain that she could not sleep at night and the pain went up and down.Patient to call back when she figures out the questions and will keep manufacturer informed.Pt reported that she has not noticed much difference from having the stimulator turned off for a few weeks and then having it turned on.Pt stated that she will be having blocks as well as an ablation and more tests.Pt said her pain dr.Told her that the stimulator will not help with the si joint problem.Pt mentioned that with the location of the battery, she can feel the corners and it feels like the battery could just come through the skin because it's so close to the top on the buttocks, and the neurosurgeon asked why they put it so low.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11147838
• MDR Text Key: 226065496
• Report Number: 3004209178-2021-00508
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/11/2021
• Date Device Manufactured: 06/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR